Instrument Flight Rule Altitudes in Designated Mountainous Areas, 63885-63886 [E8-25692]
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Federal Register / Vol. 73, No. 209 / Tuesday, October 28, 2008 / Rules and Regulations
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*2000–MOCA
*3000–GNSS MEA
§ 95.6456 ALASKA VOR FEDERAL AIRWAY V456 Is Amended To Read in Part
TUCKS, AK FIX ............................................................................
*3300–MOCA
KING SALMON, AK VORTAC ......................................................
*2300–MOCA
BITOP, AK FIX ..............................................................................
*5200–MOCA
*8000–GNSS MEA, NE BND
*6000–OPPOSITE GNSS MEA, SW BND
NOSKY, AK FIX ............................................................................
*10300–MCA TUCKS, AK FIX, SW BND
**12300–MOCA
STREW, AK FIX ............................................................................
KENAI, AK VOR/DME .................................................................
*5000
STREW, AK FIX ..........................................................................
SW BND
NE BND
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NOSKY, AK FIX ...........................................................................
*9000
*TUCKS, AK FIX ..........................................................................
**13000
BITOP, AK FIX ............................................................................
NE BND
SW BND
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*5000–GNSS MEA
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To
§ 95.7001
§ 95.7225
MEA
Jet Routes
JET ROUTE J225 Is Amended To Read in Part
CEDAR LAKE, NJ VORTAC ............................................
KENNEDY, NY VOR/DME ...............................................
[FR Doc. E8–25508 Filed 10–27–08; 8:45 am]
Background
On April 28, 1956, FAA published a
final rule revising the regulations
concerning minimum en route IFR
altitudes (21 FR 2750). Section 610.8
concerned the designation of
mountainous areas. This section was
later redesignated as § 95.13 (28 FR
6718, June 29, 1963).
When the section was originally
written, one set of coordinates for the
Eastern United States Mountainous
Region (latitude 42°13′ N, longitude 72°
44′ W) was inadvertently repeated. This
final rule removes the repeated
coordinates to avoid confusion.
18000
33000
The Amendment
BILLING CODE 4910–13–M
■
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 95
Instrument Flight Rule Altitudes in
Designated Mountainous Areas
Federal Aviation
Administration (FAA), DOT.
AGENCY:
Final rule; technical
amendment.
ACTION:
SUMMARY: The FAA is amending its
regulations concerning the use of
instrument flight rule (IFR) altitudes.
Specifically, a duplicate coordinate in
the description of the Eastern United
States Mountainous Area is being
removed.
This amendment becomes
effective October 28, 2008.
DATES:
FOR FURTHER INFORMATION CONTACT:
ebenthall on PROD1PC60 with RULES
MAA
Ellen Crum, Air Traffic Systems
Operations, Airspace and Rules Group,
ATO–R, Federal Aviation
Administration, 800 Independence
Ave., SW., Washington, DC 20591;
telephone (202) 267–8783, facsimile
(202) 267–9328.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:54 Oct 27, 2008
Jkt 217001
Technical Amendment
This technical amendment merely
removes duplicate coordinates. There
are no other changes to the list of
coordinates.
Justification for Immediate Adoption
Because this action removes
duplicated information, the FAA finds
that notice and public comment under
5 U.S.C. section 553(b) is unnecessary.
For the same reason, the FAA finds that
good cause exists under 5 U.S.C. section
553(d) for making this rule effective
upon publication.
List of Subjects in 14 CFR Part 95
Air traffic control, Airspace,
Navigation (air).
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Frm 00043
Fmt 4700
Sfmt 4700
In consideration of the foregoing, the
Federal Aviation Administration
amends Chapter I of Title 14, Code of
Federal Regulations, as follows:
PART 95—IFR ALTITUDES
1. The authority citation for part 95
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
and 14 CFR 11.49(b)(2).
2. Amend § 95.13 by revising the text
of paragraph (a) following the map to
read as follows:
■
§ 95.13 Eastern United States
Mountainous Area.
*
*
*
*
*
(a) * * *
Beginning at latitude 47°10′ N.,
longitude 67°55′ W.; thence west and
south along the Canadian Border to
latitude 45°00′ N., longitude 74°15′ W.;
thence to latitude 44°20′ N., longitude
75°30′ W.; thence to latitude 43°05′ N.,
longitude 75°30′ W.; thence to latitude
42°57′ N., longitude 77°30′ W.; thence to
latitude 42°52′ N., longitude 78°42′ W.;
thence to latitude 42°26′ N., longitude
79°13′ W.; thence to latitude 42°05′ N.,
longitude 80°00′ W.; thence to latitude
40°50′ N., longitude 80°00′ W.; thence to
latitude 40°26′ N., longitude 79°54′ W.;
thence to latitude 38°25′ N., longitude
81°46′ W.; thence to latitude 36°00′ N.,
longitude 86°00′ W.; thence to latitude
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63886
Federal Register / Vol. 73, No. 209 / Tuesday, October 28, 2008 / Rules and Regulations
33°37′ N., longitude 86°45′ W.; thence to
latitude 32°30′ N., longitude 86°25′ W.;
thence to latitude 33°22′ N., longitude
85°00′ W.; thence to latitude 36°35′ N.,
longitude 79°20′ W.; thence to latitude
40°11′ N., longitude 76°24′ W.; thence to
latitude 41°24′ N., longitude 74°30′ W.;
thence to latitude 41°43′ N., longitude
72°40′ W.; thence to latitude 42°13′ N.,
longitude 72°44′ W.; thence to latitude
43°12′ N., longitude 71°30′ W.; thence to
latitude 43°45′ N., longitude 70°30′ W.;
thence to latitude 45°00′ N., longitude
69°30′ W.; thence to latitude 47°10′ N.,
longitude 67°55′ W., point of beginning.
*
*
*
*
*
Issued in Washington, DC, on October 23,
2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. E8–25692 Filed 10–27–08; 8:45 am]
BILLING CODE 4910–13–P
and the word ‘‘mailed’’ is removed, and
the word ‘‘posted’’ is added in its place.
§ 35.14
[Corrected]
2. On page 57532, in the third column,
in § 35.14, instruction 15a is revised to
read as follows: In paragraph (a),
introductory text, the phrase ‘‘(fuel
clause)’’ is added after the phrase ‘‘Fuel
adjustment clauses’’, and the phrase ‘‘,
tariffs or service agreements’’ is added
after the phrase ‘‘rate schedules’’
anywhere it appears in the paragraph’s
introductory text.
■
Kimberly D. Bose,
Secretary.
[FR Doc. E8–25611 Filed 10–27–08; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF ENERGY
21 CFR Parts 201, 208, and 209
Federal Energy Regulatory
Commission
[Docket No. FDA–2003–N–0313] (formerly
Docket No. 2003N–0342)
18 CFR Part 35
RIN 0910–AC35
[Docket No. RM01–5–000, Order No. 714]
Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products
Electronic Tariff Filings
October 22, 2008.
AGENCY:
Federal Energy Regulatory
Commission.
ACTION: Final rule; correction.
AGENCY:
ACTION:
The Federal Energy
Regulatory Commission published a
document in the Federal Register on
October 3, 2008 (73 FR 57515), revising
Commission rules. That document
inadvertently included two nonsubstantive errors in the instructions for
the amendatory language. This
document corrects those instructions.
DATES: Effective Date: Effective on
November 3, 2008.
FOR FURTHER INFORMATION CONTACT:
Andre Goodson, Office of the General
Counsel, Federal Energy Regulatory
Commission, 888 First Street, NE.,
Washington, DC 20426, (202) 502–8560,
Andre.Goodson@ferc.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–22500 appearing on page 57515 in
the Federal Register of Friday, October
3, 2008, the following corrections are
made:
ebenthall on PROD1PC60 with RULES
SUMMARY:
§ 35.13
[Corrected]
1. On page 57532, in the second
column, in § 35.13, instruction 14g is
revised to read as follows: In paragraph
(b)(3), the word ‘‘schedule’’ is removed;
■
VerDate Aug<31>2005
14:54 Oct 27, 2008
Jkt 217001
Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule that confirms the interim final rule
entitled ‘‘Toll-Free Number for
Reporting Adverse Events on Labeling
for Human Drug Products’’ (73 FR 402,
January 3, 2008) (interim final rule) and
responds to comments submitted in
response to the request for comments in
the proposed rule of the same title (69
FR 21778, April 22, 2004) (proposed
rule). This final rule affirms the interim
final rule’s requirement for the addition
of a statement to the labeling for certain
human drug products for which an
application is approved under section
505 of the Federal Food, Drug, and
Cosmetic Act (the act). The statement
includes a toll-free number and advises
that the number is to be used only for
reporting side effects and is not
intended for medical advice (the side
effects statement). This final rule also
affirms the interim final rule’s addition
of new part 209 to the regulations
requiring distribution of the side effects
statement. This final rule implements
provisions of the Best Pharmaceuticals
for Children Act (the BPCA) and the
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Fmt 4700
Sfmt 4700
Food and Drug Administration
Amendments Act of 2007 (FDAAA).
DATES: Effective Date: This final rule is
effective November 28, 2008.
Compliance Date: The compliance
date for this final rule is July 1, 2009.
For more information on the compliance
date see section II of the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6306, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION:
I. Background
A. BPCA and Proposed Rule
The BPCA (Public Law 107–109)
directed FDA to issue a final rule
requiring the labeling of each human
drug product for which an application
is approved under section 505 of the act
(21 U.S.C. 355) to include: (1) A toll-free
number maintained by FDA for the
purpose of receiving reports of adverse
events regarding drugs and (2) a
statement that the number is to be used
for reporting purposes only, not to
receive medical advice. Collectively, we
refer to the toll-free number and
reporting statement as the ‘‘side effects
statement.’’ The BPCA stated that the
final rule must implement the labeling
requirement to reach the broadest
consumer audience and minimize the
cost to the pharmacy profession.
On April 22, 2004 (69 FR 21778), FDA
published a proposed rule entitled
‘‘Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products.’’ FDA received 22
comments on the proposed rule.
B. FDAAA Requirements and Interim
Final Rule
On September 27, 2007, the President
signed into law FDAAA (Public Law
110–85). Among other things, FDAAA
reauthorized the BPCA. Section 502(f) of
FDAAA stated that ‘‘the proposed rule
* * * ‘Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products’ * * * shall take effect
on January 1, 2008,’’ unless FDA issues
a final rule before that date. FDA was in
the process of analyzing the comments
on the proposed rule and conducting
research on consumer comprehension of
the proposed side effects statements
when FDAAA was enacted. FDA did not
issue a final rule prior to January 1,
2008. Therefore, by operation of law, the
proposed rule took effect on January 1,
2008.
FDAAA mandated one change to the
proposed rule. Section 502(f)(2) of
E:\FR\FM\28OCR1.SGM
28OCR1
]]>Agencies
[Federal Register Volume 73, Number 209 (Tuesday, October 28, 2008)]
[Rules and Regulations]
[Pages 63885-63886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25692]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 95
Instrument Flight Rule Altitudes in Designated Mountainous Areas
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The FAA is amending its regulations concerning the use of
instrument flight rule (IFR) altitudes. Specifically, a duplicate
coordinate in the description of the Eastern United States Mountainous
Area is being removed.
DATES: This amendment becomes effective October 28, 2008.
FOR FURTHER INFORMATION CONTACT: Ellen Crum, Air Traffic Systems
Operations, Airspace and Rules Group, ATO-R, Federal Aviation
Administration, 800 Independence Ave., SW., Washington, DC 20591;
telephone (202) 267-8783, facsimile (202) 267-9328.
SUPPLEMENTARY INFORMATION:
Background
On April 28, 1956, FAA published a final rule revising the
regulations concerning minimum en route IFR altitudes (21 FR 2750).
Section 610.8 concerned the designation of mountainous areas. This
section was later redesignated as Sec. 95.13 (28 FR 6718, June 29,
1963).
When the section was originally written, one set of coordinates for
the Eastern United States Mountainous Region (latitude 42[deg]13' N,
longitude 72[deg] 44' W) was inadvertently repeated. This final rule
removes the repeated coordinates to avoid confusion.
Technical Amendment
This technical amendment merely removes duplicate coordinates.
There are no other changes to the list of coordinates.
Justification for Immediate Adoption
Because this action removes duplicated information, the FAA finds
that notice and public comment under 5 U.S.C. section 553(b) is
unnecessary. For the same reason, the FAA finds that good cause exists
under 5 U.S.C. section 553(d) for making this rule effective upon
publication.
List of Subjects in 14 CFR Part 95
Air traffic control, Airspace, Navigation (air).
The Amendment
0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of Title 14, Code of Federal Regulations, as follows:
PART 95--IFR ALTITUDES
0
1. The authority citation for part 95 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, and 14 CFR
11.49(b)(2).
0
2. Amend Sec. 95.13 by revising the text of paragraph (a) following
the map to read as follows:
Sec. 95.13 Eastern United States Mountainous Area.
* * * * *
(a) * * *
Beginning at latitude 47[deg]10' N., longitude 67[deg]55' W.;
thence west and south along the Canadian Border to latitude 45[deg]00'
N., longitude 74[deg]15' W.; thence to latitude 44[deg]20' N.,
longitude 75[deg]30' W.; thence to latitude 43[deg]05' N., longitude
75[deg]30' W.; thence to latitude 42[deg]57' N., longitude 77[deg]30'
W.; thence to latitude 42[deg]52' N., longitude 78[deg]42' W.; thence
to latitude 42[deg]26' N., longitude 79[deg]13' W.; thence to latitude
42[deg]05' N., longitude 80[deg]00' W.; thence to latitude 40[deg]50'
N., longitude 80[deg]00' W.; thence to latitude 40[deg]26' N.,
longitude 79[deg]54' W.; thence to latitude 38[deg]25' N., longitude
81[deg]46' W.; thence to latitude 36[deg]00' N., longitude 86[deg]00'
W.; thence to latitude
[[Page 63886]]
33[deg]37' N., longitude 86[deg]45' W.; thence to latitude 32[deg]30'
N., longitude 86[deg]25' W.; thence to latitude 33[deg]22' N.,
longitude 85[deg]00' W.; thence to latitude 36[deg]35' N., longitude
79[deg]20' W.; thence to latitude 40[deg]11' N., longitude 76[deg]24'
W.; thence to latitude 41[deg]24' N., longitude 74[deg]30' W.; thence
to latitude 41[deg]43' N., longitude 72[deg]40' W.; thence to latitude
42[deg]13' N., longitude 72[deg]44' W.; thence to latitude 43[deg]12'
N., longitude 71[deg]30' W.; thence to latitude 43[deg]45' N.,
longitude 70[deg]30' W.; thence to latitude 45[deg]00' N., longitude
69[deg]30' W.; thence to latitude 47[deg]10' N., longitude 67[deg]55'
W., point of beginning.
* * * * *
Issued in Washington, DC, on October 23, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. E8-25692 Filed 10-27-08; 8:45 am]
BILLING CODE 4910-13-P
